There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study was to determine occurrence of ventilator associated pneumonia (VAP) in tracheostomized patients with COPD discharged in invasive mechanical ventilation (IMV) compared to patients with CPOPD discharged with tracheostomy but in non invasive mechanical ventilation (NIMV).
The general area of research in which this project has been designed is that of retinal degeneration related to mutations in the ABCR gene, responsible of Stargardt disease/fundus flavimaculatus retinal dystrophy (STD/FF). STG/FF is one of the major causes of vision impairment in the young age. STG/FF originates typically from the dysfunction and loss of cone and rod photoreceptors, developing through a photo-oxidative mechanism. The major disease locus is the central retina, i.e. the macula, whose neurons have the highest density and underlie critical functions such as visual acuity, color vision and contrast sensitivity. There is currently no cure for STG/FF. Recent experimental findings indicate that Saffron, derived from the pistils of Crocus Sativus, may have a role as a retinal neuro-protectant against oxidative damage. The stigmata of Crocus sativus contain biologically high concentrations of chemical compounds including crocin, crocetin, whose multiple C=C bonds provide the antioxidant potential. In addition it is well known that this compound is safe and free of adverse side effects. The aim of this research is to investigate the influence of short-term Saffron supplementation on retinal function in STG/FF patients carrying ABCR mutations. The macular cone-mediated electroretinogram (ERG) in response to high-frequency flicker (focal flicker ERG) will be employed as the main outcome variable. Secondary outcome variable will be the psychophysical cone system recovery after bleaching.
Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation Duration: The patients are enrolled for the time of the blood withdrawl. Follow up visit will be after 12 months from the enrollement. Objectives: The project will have two major objectives: A)To validate the prognostic value of vascular progenitor cells, identified by flow cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes complicated by ischemic foot ulcers. Events are: cardiovascular mortality, major amputation, post-angioplasty restenosis , and development of new atherosclerotic plaques in treated limb B)To determine the mechanisms responsible for vascular progenitor cell dysfunction in the perspective of new therapies for the cure of the diabetic foot.
300 italian women will be enroll for linguistic and cultural validation in italian of Female sexual function index (FSFI). This questionnaire is used in most countries to investigate female sexual function. To date there are not validate questionnaires in italian on female sexual function. We decided to start the validation process to give a validated tool to italian investigators.
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
In 1991 the Medical Research Council Vitamin Study Group and in 1992 the Hungarian randomised clinical trial have shown conclusively that the risk of neural tube defects can be reduced substantially by taking folic acid during the peri-conceptional period. At present there is enough evidence to support the hypothesis that folic acid supplementation can reduce the risk of all congenital malformations or of a specific and selected group of them, namely: neural tube defects, oral clefts, cardiac defects, urinary tract anomalies except hypospadias, limb reduction defects, omphalocele, anal atresia and trisomy 21. The hypothesis that a higher intake of folic acid is related to an higher risk reduction of neural tube defects and of other congenital malformations is the main rationale for the present study. The present study is a randomized, double-blind, controlled trial evaluating whether supplementation with folic acid at high dose (4 mg/day) reduces the overall risk of major congenital malformations in the population more than the standard recommended dose (0.4 mg/day). At the enrolment visit all the eligible women will be interviewed to assess sociodemographic, life style and health status. After randomization, women will be interviewed every 4 months to evaluate pregnancy status. Women who have a pregnancy diagnosis during the study period will be interviewed by telephone at the expected 16, 24 and 40 weeks of gestation to evaluate the pregnancy outcome. The health status of live births will be evaluated at the child's age of 1 month, 3 months and 1 year. The primary aim of this project is conducting a study to assess the effect of folic acid periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on reducing the occurrence of all congenital malformations. Secondary aims of this study include comparing severity of CMs in offspring of trial mothers, rates of "selected congenital malformations", rates of twinning, miscarriages, recurrent abortions, small-for-gestational age, preeclampsia and abruptio placentae. The sample size is not easy to be computed because lacking robust estimate of the size effect of the treatment. Three hypotheses of a size effect of 45%, 26% and 13% were considered. A sample size of outcomes (and women) respectively of 2,006 (5,015), 8,510 (21,275) and 30,126 (75,315) is needed. Since the sample size needed to evaluate different scenarios is large, the present study is also the pilot study to promote an international prospective meta-analysis.
Despite several clinical trials have clearly demonstrated that the correction of a single cardiovascular risk factor in patients with type 2 diabetes decreases the incidence of myocardial infarction and other cardiovascular disease (CVD) events, only the Steno study has been evaluating the effect of a multifactorial intervention strategy on macrovascular complications of diabetes. For this reason, the disease management approach currently endorsed by international guidelines (i.e correction of all major CVD risk factors to target levels usually lower than lower risk populations) has not been extensively investigated in terms of prevalence of application in current clinical practice and in terms of real efficacy. The Multifactorial INtervention in type 2 Diabetes - ITaly (MIND.IT) is a multicentric two-phase study involving 9 Diabetes Care Units throughout Italy with the overall aims of: (1) investigating the degree of application of the international guidelines for CVD prevention in type 2 diabetic patients and (2) verifying whether the application of an intensive multi-factorial intervention inspired by these guidelines is feasible and effective in decreasing the incidence of new CVD events.
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice. A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III